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Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders (EDILS-AutoAC)

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ClinicalTrials.gov Identifier: NCT03510533
Recruitment Status : Unknown
Verified April 2018 by University Hospital, Rouen.
Recruitment status was:  Not yet recruiting
First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Study Description
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Brief Summary:
This study should lead to the validation of the concept of the autoAc directed against the neuropeptides involved in food intake regulation.

Condition or disease Intervention/treatment Phase
Eating Disorder Other: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation Not Applicable

Detailed Description:

Eating disorders are a public health issue. It has been recently reported the importance of immune system modifications in eating disorders physiopathology, involving autoantibodies directed against neuropeptides regulating food intake. A recent study of laboratory INSERM 1073 showed the existence of an intestinal bacterial protein exhibiting structural similarities with α-MSH: ClpB. The autoAc directed against the latter also react with α-MSH because of these similarity of structures, thus leading to a potential digestive origin of these autoAc. To consolidate this new etiopathogenic assumption, a large clinical study is necessary with analysis of patients autoAc profiles. a monocentric study with inclusion of 240 patients over 2 years and 80 healthy volunteers is proposed.

This study should lead to the validation of the concept of the autoAc directed against the neuropeptides involved in food intake regulation. Nutritional modulations (probiotic, amino-acid…) could constitute an interesting therapeutic perspective in the future.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eating disorders compared to healthy volonteers
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : January 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Eating disorders patients
first clinical visit in nutrition department of CHU de Rouen for eating disorders (anorexia nervosa, hyperphagia or bulimia) according to the classification DSM-V
 Other: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation
blood samples (12ml) and stool samples (30g) collections
Other Names:
  • Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB
  • Factors associated with eating disorders
healthy volunteers
Volunteers with negative SCOFF test (No active or history of eating disorders)
 Other: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation
blood samples (12ml) and stool samples (30g) collections
Other Names:
  • Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB
  • Factors associated with eating disorders


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) involved in food intake regulation among patients with eating disorders [ Time Frame: 1 week ]
    blood samples collections


Secondary Outcome Measures :
  1. Scale for determination factors associated with eating disorders [ Time Frame: 1 week ]

    A global scale will evaluate :

    • socio demographic factors
    • somatic and psychiatric comorbidities
    • addictions
    • personal and family antecedents
    • major events

  2. statute in autoantibody and behavioral characteristics of the eating disorder [ Time Frame: 1 week ]
    quality of life and the psychological state of the patients tests

  3. Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB among patients presenting with eating disorders [ Time Frame: 1 week ]
    stoll samples collections


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients with eating disorders

  1. 18 Years and older
  2. first clinical visit in nutrition department of CHU de Rouen for eating disorders
  3. anorexia nervosa, hyperphagia or bulimia according to the classification DSM-V
  4. social security Affiliation
  5. Patient who signed the MEC approved informed consent

Volunteers

  1. 18 Years to 60 Years
  2. body mass index ≥ 18,5 kg/m2 and ≤ 24,9 kg/m2
  3. negative SCOFF test
  4. No active and history of eating disorders
  5. social security Affiliation
  6. volunteer who signed the MEC approved informed consent

Exclusion criteria:

Patients with eating disorders

  1. No anorexia nervosa, hyperphagia or bulimia according to the classification DSM-V
  2. Adults under legal protection or under safeguard of justice or administrative decision
  3. Pregnancy

Volunteers

  1. Active or history of eating disorder
  2. Adults under legal protection or under safeguard of justice or administrative decision
  3. Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03510533


Contacts
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Contact: Najate EL MACHKOURI ACHAMRAH, MD, PhD 2 32 88 57 05 ext +33 Najate.Achamrah@chu-rouen.fr
Contact: Pierre DECHELOTTE, Pr 2 32 88 64 65 ext +33 Pierre.Dechelotte@chu-rouen.fr

Locations
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France
Centre d'Investigation Clinique
Rouen, France, 76031
Contact: Marie-Pierre TAVOLACCI, Ph, D    2 32 88 88 62 ext +33    MP.Tavolacci@chu-rouen.fr   
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Najate EL MACHKOURI ACHAMRAH, MD, PhD Rouen University Hospital
More Information
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT03510533    
Other Study ID Numbers: 2016/107/HP
2017-A00875-48 ( Other Identifier: Agence Nationale de Sécurité du médicament et des produits de Santé )
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Rouen:
autoantibodies (autoAc) circulating
neuropeptides (Ghrelin, l'α-MSH)
potential digestive origin
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Mental Disorders
Autoantibodies
alpha-MSH
 Immunologic Factors
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists